Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients

Prostate Cancer Clinical Trial

Official title:

A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Volume Reduction of the Prostate in Patients With Prostate Cancer Being Candidates for Medical Castration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884273
• Other study ID #: FE200486 CS31
• Secondary ID: 2008-008604-40
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2009
• Last updated: October 21, 2013
• Start date: August 2009
• Est. completion date: March 2011

Study information

• Verified date: October 2013
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencySweden: Medical Products AgencyFinland: Finnish Medicines AgencyNorway: Norwegian Medicines AgencyPortugal: National Pharmacy and Medicines InstituteItaly: The Italian Medicines AgencyBelgium: Federal Agency for Medicinal Products and Health ProductsTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume.

The hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a GnRH agonist with an anti-androgen for flare protection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient has given written informed consent

2. Patient is 18 years or older

3. Patient has histologically confirmed prostate cancer

4. Patient has a serum prostate-specific antigen (PSA) level at screening >2 ng/mL

5. The prostate size is >30 cubic centimetres (cc), measured by TRUS

6. Patient has had a bone-scan within 12 weeks before inclusion

7. Patient must be able to undergo transrectal examinations

8. Patient has an estimated life expectancy of at least 12 months

Exclusion Criteria:

1. Any previous treatments for prostate cancer

2. Previous trans-urethral resection of the prostate (TURP)

3. Is not considered a candidate for medical castration

4. Use of urethral catheter

5. Is currently treated with a 5-alpha reductase inhibitor

6. Is currently treated with an alpha-adrenoceptor antagonist

7. Treatment with botulinum toxin A (Botox)

8. Require radiotherapy during the trial

9. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema

10. Hypersensitivity towards any component of the investigational products or excipients

11. Previous history or presence of another malignancy

12. A clinically significant disorder

13. A corrected QT interval over 450 msec

14. Mental incapacity or language barrier precluding adequate understanding or co-operation

15. Receipt of an investigational drug within the last 28 days proceeding screening

16. Previous participation in any degarelix trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
• Goserelin
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
• Bicalutamide
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.

Locations

Country	Name	City	State
Belgium	Hospital St Jan Brugge	Brugge
Belgium	Institut Jules Bordet	Bruxelles
Belgium	University Hospitals Leuven	Leuven
Belgium	St. Elisabethziekenhuis	Turnhout
Denmark	Aalborg Sygehus syd	Aalborg
Denmark	Århus Universitetshospital, Skejby	Århus
Denmark	Herlev Hospital	Ballerup
Denmark	Regionhospitalet Holstebro	Holstebro
Denmark	Sygehus Syd, Næstved Sygehus	Næstved
Denmark	Roskilde Sygehus	Roskilde
Finland	HYKS/kirurgian klin./urologia	Helsinki
Finland	KYS/kirurgian klin (Kuopio)	Kuopio
Finland	OYS/kirurgian klinik	Oulu
Finland	TAYS/kirurgian klinik	Tampere
Italy	Azienda Ospedaliero Universitaria Ospedali riuniti	Ancona
Italy	Azienda Ospedaliera S. Giuseppe Moscaaati	Avellino
Italy	Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna	Bologna
Italy	U.O. Di Urologia - Spedali Civili di Brescia	Brescia
Italy	Clinica Urologica 1 Universita. Firensa	Firenze
Italy	Fondazione IRCCS Istituto Nazionale Tumori	Milano
Italy	Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena	Milano
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo	Palermo
Italy	Clinica Urologica - Azienda Ospedaliera di Perugia	Perugia
Italy	Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma	Roma
Italy	S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo
Italy	Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette	Torino
Norway	Moelv spesialistsenter	Moelv
Norway	Aker Universitetssykehus HF	Oslo
Norway	Det Norske Radiumhospitalet HF	Oslo
Norway	St Olavs Hospital HF	Trondheim
Portugal	Hospital Fernando da Fonseca	Amadora
Portugal	Hospitais Universidade Coimbra	Coimbra
Portugal	Centro Hospitalar Lisboa Norte, Hospital Santa Maria	Lisboa
Portugal	Hospital S.João	Porto
Sweden	Investigational site	Göteborg
Sweden	SU/Sahlgrenska	Göteborg
Sweden	Helsingborgs Lasarett	Helsingborg
Sweden	Universitetssjukhuset MAS	Malmö
Sweden	Södertälje Sjukhus	Södertälje
Sweden	Uppsala/Akademiska sjukhuset	Uppsala
Turkey	Cerrahpasa Faculty of Medicine, Kocamustafapasa	Istanbul
Turkey	Istanbul University Faculty of Medicine, ÇAPA	Istanbul
Turkey	Marmara University Faculty of Medicine, Altunizade	Istanbul
Turkey	Ankara University Faculty of Medicine	Sihhiye - Ankara
Turkey	Hacettepe University Faculty of Medicine	Sihhiye - Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Denmark,  Finland,  Italy,  Norway,  Portugal,  Sweden,  Turkey, 

References & Publications (1)

Axcrona K, Aaltomaa S, da Silva CM, Ozen H, Damber JE, Tankó LB, Colli E, Klarskov P. Androgen deprivation therapy for volume reduction, lower urinary tract symptom relief and quality of life improvement in patients with prostate cancer: degarelix vs gose — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)	TRUS is a method of measuring the size of the prostate.	After treatment of 12 weeks compared to Baseline	No
Primary	Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)	TRUS is a method of measuring the size of the prostate.	After treatment of 12 weeks compared to Baseline	No
Secondary	Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8	TRUS is a method of measuring the size of the prostate.	After treatment of 4 and 8 weeks compared to Baseline	No
Secondary	Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12	The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.	After treatment of 4, 8, and 12 weeks compared to Baseline	No
Secondary	Change in Serum Testosterone Levels During the Study		At 4, 8, and 12 weeks compared to baseline.	No
Secondary	Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study		At 4, 8, and 12 weeks compared to baseline.	No
Secondary	Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit	The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').	After treatment of 4, 8, and 12 weeks compared to Baseline	No
Secondary	Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)	The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire to measure how much urinary problems affect various domains of health. The higher value the worse are the urinary problems. The minimum possible total value is 0 and the maximum possible total value is 16.	After treatment of 4, 8, and 12 weeks compared to Baseline	No
Secondary	Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.	Baseline to 12 weeks of treatment	No
Secondary	Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables	The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.	Baseline to 12 weeks of treatment	No